I. Market scale

According to EvaluateMedtech, the market size of Chinese medical equipment has been growing rapidly in recent years, the market size increased from 370 billion yuan in 2016 to 765.5 billion yuan in 2020, with an average annual compound growth rate of 19.9%. It is estimated that the market size of Chinese medical equipment will reach 125.29 billion yuan in 2022.

The Ministry of Finance has repeatedly stated that China adheres to the principles of openness, transparency and fair competition in government procurement, and ensures fair participation of domestic and foreign enterprises in government procurement competition.

Recently, the Medical Device Standards Management Center of the NMPA released the Summary of the Third Classification and Definition Results of Medical Device Products in 2022, and 75 medical devices were directly excluded.

On October 31, the NMPA issued the Notice on Seeking Adjustment Opinions on the Classified Catalogue of Medical Devices (hereinafter referred to as the “Notice”), asking for adjustment opinions on the 57 categories of medical devices related to the Classified Catalogue of Medical Devices.

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If your active medical device was approved by the China NMPA before 2021, most likely, you are not compliant with the newly upgraded Chinese national standard GB 9706.1-2020.